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Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Chest and Back

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT00783965
First received: October 31, 2008
Last updated: July 29, 2013
Last verified: July 2013

October 31, 2008
July 29, 2013
July 2004
June 2012   (final data collection date for primary outcome measure)
  • Reduction in the observed numbers of basal cell carcinomas ≥ 9 mm² in diameter [ Designated as safety issue: No ]
  • Parameters of safety [ Designated as safety issue: Yes ]
  • Adverse events according to NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00783965 on ClinicalTrials.gov Archive Site
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Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Chest and Back
A Phase II Randomized, Double-Blind, Vehicle-Controlled, Crossover Clinical Trial of Tazarotene 0.1% and Vehicle Cream Each Applied Once-Daily for 12 or 24 Months in Subjects With Basal Cell Nevus Syndrome

RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This randomized phase II trial is comparing two different schedules of topical tazarotene and topical placebo to see how well they work in treating patients with basal cell skin cancer and basal cell nevus syndrome on the chest.

OBJECTIVES:

Primary

  • To expand and refine chemopreventive strategies in individuals with basal cell nevus syndrome (BCNS) on the chest and back, who are at high risk for the development of basal cell carcinomas (BCCs).
  • To determine whether tazarotene 0.1% cream applied to the chest for two years will reduce the numbers of basal cell carcinomas (BCCs) observed, as compared to the number expected, based on changes in BCC numbers observed during months 0-12.

Secondary

  • To compare the difference in total BCC burden (measured as the total lesion surface area) between chest and back over various time points and aggregated intervals of interest.
  • To determine whether there are any detectable wash-in or wash-out periods for the tazarotene effects.
  • Explore the use of a random effects model for longitudinal analysis of total lesions over time.

OUTLINE: This is a multicenter study. Patients are randomized into 1 of 2 arms.

  • Arm I: Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients apply vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest in the absence of disease progression or unacceptable toxicity.

Treated chest and untreated back is evaluated at 3 month intervals for 36 months.

Interventional
Phase 2
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
  • Neoplastic Syndrome
  • Non-melanomatous Skin Cancer
  • Drug: tazarotene
    Applied to the skin
  • Other: placebo
    Applied to the skin
  • Experimental: Arm I
    Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.
    Interventions:
    • Drug: tazarotene
    • Other: placebo
  • Experimental: Arm II
    Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.
    Interventions:
    • Drug: tazarotene
    • Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Not Provided
June 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or clinically diagnosed with at least 3 basal cell carcinomas (BCCs) ≥ 9 mm² in diameter on both the chest and back within the past year
  • Meets above criterion as well as one additional major criterion or two minor criteria:

    • Major criteria:

      • More than 2 histologically confirmed BCCs (1 for patients under the age of 20 years)
      • Odontogenic keratocysts of the jaw proven by histology
      • Three or more palmar and/or plantar pits
      • Bilamellar calcification of the falx cerebri (if less than 20 years old)
      • Fused, bifid, or markedly splayed ribs
      • First degree relative with basal cell nevus syndrome (BCNS)
      • PTCH1 gene mutation in normal tissue
    • Minor criteria:

      • Macrocephaly determined after adjustment for height
      • Congenital malformations (e.g., cleft lip or palate, frontal bossing, "coarse face", moderate or severe hypertelorism)
      • Skeletal abnormalities (e.g., Sprengel deformity, marked pectus deformity, or marked syndactyly of the digits)
      • Radiological abnormalities (e.g., bridging of the sella turcica, vertebral anomalies such as hemivertebrae, fusion or elongation of the vertebral bodies, modeling defects of the hands and feet, or flame shaped lucencies of the hands or feet)
      • Ovarian fibroma
      • Medulloblastoma

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of invasive cancer within the past five years except nonmelanoma skin cancer, stage I cervical cancer, or stage 0 chronic lymphocytic leukemia
  • No history of hypersensitivity to any of the ingredients in the study medication formulations
  • No uncontrolled systemic disease, including known HIV positivity
  • No history of other skin conditions or significant illness that would interfere with evaluation of the study medication
  • No history of any condition or situation that, in the opinion of the Investigator, might interfere with the patient's ability to comply with the protocol or pose additional or unacceptable risk to the patient
  • Able to return for follow-up tests

PRIOR CONCURRENT THERAPY:

  • No prior topical or systemic therapies that might interfere with the evaluation of the study medication including the following:

    • Glucocorticoids (other than ≤ 1% triamcinolone)
    • Retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) within the past six months
    • Alpha-hydroxy acids (e.g., glycolic acid, lactic acid)
    • At least 6 months since prior 5-fluorouracil or imiquimod (except as treatment to discrete basal cell carcinomas)
    • At least 30 days since prior systemic investigational medication or any topical investigational medication to the chest or back
    • At least 1 year since prior treatment with systemic chemotherapy
  • No concurrent non-study topical medications to the skin of the chest and back, including prescription and over the counter preparations (e.g., corticosteroids [other than ≤ 0.1% triamcinolone applied no more than 6 times/month] or vitamin A)
  • Concurrent moisturizers and emollients are allowed
  • Patients must use sunscreen (SPF ≥ 15) at least once daily on all exposed skin sites during study treatment
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00783965
CDR0000618240, CHORI-2007-022, CHORI-H473-26042
Yes
Ervin Epstein, Jr, Children's Hospital Oakland Research Institute
Children's Hospital & Research Center Oakland
National Cancer Institute (NCI)
Principal Investigator: Ervin Epstein, MD Children's Hospital & Research Center Oakland
Principal Investigator: David R. Bickers, MD Herbert Irving Comprehensive Cancer Center
Children's Hospital & Research Center Oakland
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP